PMA P180001S003

Device: Zenith® Dissection Endovascular System
Applicant: William Cook Europe Aps
PMA number: P180001
Supplement: S003
Product code: MIH
Decision date: 2021-12-15
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: Change to the delivery system trigger-wire coating facility and updates to the acceptance criteria used in testing of the trigger wires.

Current openFDA PMA Record#

Device: Zenith® Dissection Endovascular System
Applicant: William Cook Europe Aps
PMA number: P180001
Supplement: S003
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2021-12-15
Decision code: OK30
Date received: 2021-11-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to the delivery system trigger-wire coating facility and updates to the acceptance criteria used in testing of the trigger wires.